FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,281 results for "health"
3145–3168 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 18, 2002
BAXTER ACCURA SYSTEM, MODEL 5M5660
K021615 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 186d
Cleared Nov 14, 2002
V TENS PLUS
K022731 · GZJ
Body Clock Health Care, Ltd.
Neurology · 90d
Cleared Nov 13, 2002
MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND...
K023153 · LYY
Ansell Healthcare Products, Inc.
General Hospital · 51d
Cleared Nov 13, 2002
JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE
K023054 · MQX
Mandala Health Care, LLC
General Hospital · 61d
Cleared Nov 13, 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
K022784 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 83d
Cleared Nov 08, 2002
NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES
K022572 · LZA
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 98d
Cleared Nov 08, 2002
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200
K021240 · DXN
Eikon Healthcare Device Corp.
Cardiovascular · 204d
Cleared Nov 08, 2002
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M
K021239 · DXN
Eikon Healthcare Device Corp.
Cardiovascular · 204d
Cleared Nov 07, 2002
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
K023039 · BRZ
Tuta Healthcare Pty Limited
General Hospital · 56d
Cleared Nov 06, 2002
DRAPES WITH ABSORBENT REINFORCEMENT
K023425 · KKX
Allegiance Healthcare Corp.
General Hospital · 26d
Cleared Nov 01, 2002
PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US
K020886 · BZD
Tyco Healthcare Nancy
Anesthesiology · 228d
Cleared Oct 25, 2002
MODIFICATION TO ESOP CO-CR FEMORAL HEADS
K023375 · LPH
Pro-Active Healthcare
Orthopedic · 17d
Cleared Oct 22, 2002
HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC
K022737 · KPR
Health Care Mfg., Inc.
Radiology · 64d
Cleared Oct 22, 2002
HCMI X-RAY
K022667 · KPR
Health Care Mfg., Inc.
Radiology · 71d
Cleared Oct 17, 2002
SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)
K022924 · IOR
Otto Back Healthcare, LP
Physical Medicine · 43d
Cleared Oct 11, 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K022765 · LZA
Allegiance Healthcare Corp.
General Hospital · 52d
Cleared Oct 11, 2002
EMS 400
K022493 · IPF
Body Clock Health Care, Ltd.
Physical Medicine · 74d
Cleared Oct 09, 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K023170 · LZA
Allegiance Healthcare Corp.
General Hospital · 16d
Cleared Oct 09, 2002
FRYE ADJUSTING INSTRUMENT
K021238 · LXM
Frye Health Systems
Physical Medicine · 174d
Cleared Oct 02, 2002
BREATHABLE SURGICAL GOWN
K023167 · FYA
Allegiance Healthcare Corp.
General Hospital · 9d
Cleared Oct 01, 2002
PMX DISPOSABLE BAG MASK RESUSCITATOR
K014071 · BTM
Allied Healthcare Products, Inc.
Anesthesiology · 295d
Cleared Sep 24, 2002
FIRST CHOICE & FIRST CHOICE PLUS
K022076 · GZJ
Body Clock Health Care, Ltd.
Neurology · 90d
Cleared Sep 19, 2002
DVT60
K022786 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 28d
Cleared Sep 11, 2002
RADIONICS POLE NEEDLES
K021942 · GXI
Radionics, A Division of Tyco...
Neurology · 90d